Microbiology Specialist

Job Description Summary

If youre driven by protecting patients through rigorous contamination control and scientific excellence this is your opportunity to make a meaningful impact every day. As a Microbiology Specialist youll play a critical role in ensuring the quality safety and integrity of our products by leading microbiological testing method verification and environmental monitoring activities within a highly regulated manufacturing environment. Youll partner closely with cross-functional teams to support investigations qualifications and continuous improvement initiatives while applying your expertise to data review trending and technical documentation. This role offers the chance to work hands-on with advanced microbiology processes influence site readiness and serve as a trusted subject matter expertcontributing directly to Novartis mission to deliver high-quality medicines to patients worldwide.

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Location: Durham NC USA

Shift: 1st shift 2 positions available

This role is based in Durham NC USA. Novartis is unable to offer relocation support: please only apply if this location is accessible for you.

Job Description

• Perform microbiological qualification release stability and investigational testing to support compliant manufacturing operations.
• Author and maintain protocols and reports for microbiology and environmental monitoring method verification and validation activities.
• Execute method transfers and verifications for microbiology and environmental monitoring assays across laboratory systems.
• Maintain qualification control and trending of critical reagents standards and microbiology controls.
• Review and approve routine and transfer data supporting deviations change controls and quality investigations.
• Coordinate environmental monitoring performance qualification site assessments media fills and utilities qualification activities.
• Perform microbiological testing of materials utilities and environmental and personnel monitoring samples.
• Analyze trends and performance indicators while supporting sample planning and execution across laboratory activities.

• Bachelors degree in biochemistry biology microbiology or a related scientific discipline.
• Minimum five years of experience working in a Good Manufacturing Practice environment.
• Proven experience performing microbiological testing including utilities testing and environmental and personnel monitoring.
• Demonstrated ability to write protocols verification documentation and technical reports using Good Documentation Practice.
• Experience reviewing and approving laboratory data supporting deviations investigations and change controls.
• Strong knowledge of Good Laboratory Practice and Good Documentation Practice principles.
• Understanding of United States Food and Drug Administration and European Medicines Agency regulatory expectations.
• Ability to gown for entry into aseptic areas and lift approximately 25 pounds.

The salary for this position is expected to range between $43.07/hour and $80.00/hour. The final salary offered is determined based on factors such as relevant skills experience and market considerations and will be reviewed periodically upon joining Novartis. Novartis may adjust the published salary range based on company and market factors. Compensation includes eligibility for a performance-based incentive.

U.S.-based eligible employees will receive a comprehensive benefits package including health life and disability insurance a 401(k) with company contribution and match and generous paid time off.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$89600.00 - $166400.00

Skills Desired

Collaboration Communication Skills Data Integrity Dealing With Ambiguity Decision Making Digital saviness Leadership Problem Solving Skills Regulatory Requirements knowledge